Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03425526
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Immunocompromised

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes — BIOLOGICAL
    Given IV

Study Details

This phase I trial studies the side effects of allogeneic adenovirus-specific cytotoxic T lymphocytes (donor T cell therapy) and to see how well they work in treating patients with a weakened immune system (immunocompromised) and adenovirus-related disease. Allogeneic adenovirus-specific cytotoxic T lymphocytes are made from donated blood cells grown in the laboratory and are designed to kill viruses that can cause infections in immunocompromised patients with adenovirus-related disease.

Key Dates

Start date
Mar 15, 2018
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (allogeneic adenovirus-specific CTLs)
    Within two weeks of enrollment, patients receive allogeneic adenovirus-specific CTLs IV over 30 minutes. Patients may receive additional allogeneic adenovirus-specific CTL infusions at the discretion of the investigator in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.0 [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
David Marin
713-792-8750
David Marin (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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